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What Comes After COVID? UK Experts Debate Future of a Diagnostics Landscape Transformed


NEW YORK – The COVID-19 pandemic has inarguably been transformative for the UK molecular diagnostics sector. Faced with unprecedented challenges, policymakers liaised with academic and industry partners and better aligned existing infrastructure to carry out SARS-CoV-2 testing at scale, while introducing new resources to meet the public's health needs.

Now, as the nation, along with the rest of the world, continues to try to get a handle on the pandemic, industry experts caution that the changes made during the past two and a half years should not be reversed. Instead, the challenges faced since early 2020 are an opportunity to make over UK diagnostics for good, "catalyzing a shift in focus and mindset," as several UK researchers advocated in an April letter to The Lancet.

Dimitris Grammatopoulos, a professor of molecular medicine at the University of Warwick and an NHS consultant in clinical biochemistry at the University Hospital Coventry and Warwickshire NHS Trust, authored the letter, together with Lawrence Young, a professor of molecular oncology at the same institution, and Neil Anderson, the clinical director of the Coventry and Warwickshire NHS Pathology Services.

In their letter, the authors pushed for continued engagement with front-line pathology and laboratory services and professional organizations and highlighted the role of the pandemic in prompting labs to successfully redeploy staff and resources to carry out high-throughput SARS-CoV-2 testing as well as to contribute to services, such as the COVID-19 Genomics UK Consortium and the UK National Health Service's Test and Trace technical validation groups.

There was also a need to quickly funnel biomarkers and new recommendations into clinical practice to manage treatment of COVID-19 patients. Collaborations with academia and industry yielded NHS-led innovation, the authors wrote, who called for a continuation of such partnerships. To be better prepared for future pandemics and to implement precision medicine, the UK diagnostics landscape needs to optimize services cooperation and integration, they said.

In an interview Grammatopoulos said that the Lancet article was an "introductory step" toward a new consensus around diagnostics in the UK. At the start of the pandemic, diagnostics in the UK was mostly organized around NHS laboratories, with some specialty services made available via Public Health England. But COVID-19 encouraged the NHS to tap into the expertise and technologies embedded in industry and academia — by using next-generation sequencing for disease surveillance, for example, via the COVID-19 Genomics UK Consortium. "This was almost like an academic initiative," remarked Grammatopoulos. "It was this particular expertise that was missing from NHS diagnostic labs," he said. "Looking ahead, these are areas where the NHS needs to build capacity, expertise, and the right people to deliver a diagnostics service at the forefront of development."

There is, of course, more to the matter. Grammatopoulos said the pandemic showed there is a need to diversify diagnostic setups beyond traditional NHS labs to facilitate the translation of innovation and multidiscipline services integration. This has shifted the dialogue away from the challenge of the pandemic, and toward how to position the UK's diagnostic infrastructure — state-run, academic, and industry — going forward.

"Maybe we should start thinking differently about investment and how to interact with industry and academia, the triple helix as we call it," said Grammatopoulos. "All of these questions are now coming into the agenda."

A slew of reports

Such questions have been under debate more or less since the pandemic began in Europe, and have resulted in several reports on how to best realign UK diagnostics after COVID-19. 

In August 2020, the Association of British HealthTech Industries (ABHI) published Diagnostics: A Future Roadmap, in which the healthtech industry association laid out five recommendations to guide UK diagnostics in the future. They called for the development of national oversight and leadership of a holistic approach to diagnostics; the placement of diagnostics at the center of population health management; ensuring the systems and resources to build on existing collaborations; maintaining the infrastructure put in place to support COVID-19 testing; and putting "critical enablers" in place to speed uptake of innovative diagnostics into the healthcare system.

According to Nishan Sunthares, managing director of diagnostics at ABHI, the report is still relevant two years on. He said this week that the UK government is currently developing a new medtech strategy through the Department of Health and Social Care that could be published soon, a component of which will focus specifically on diagnostics.

"Specifically, it will concentrate on efforts to help reduce the diagnostics backlog, support the early diagnosis agenda, and ensure preparedness for future pandemics, as well as any necessary scaling up of testing for COVID outbreaks," Sunthares noted.

He added that the UK is working to implement a more comprehensive approach to testing, specifically via NHS England, and that ABHI is continuing to push for the establishment of a national diagnostics director. There has been more funding made available for infrastructure, too. At the same time, COVID-19 testing infrastructure is being decommissioned, a decision that Sunthares called a "lost opportunity to build and deploy new diagnostic service delivery models."

The biggest change facing UK diagnostics, Sunthares pointed out, is actually a shift in the regulatory environment, as a post-Brexit UK implements its own system for assessing the compliance of in vitro diagnostics, as well as its own conformity mark, the UKCA. Sunthares said that ABHI is engaged in ensuring the future UK system is "aligned to regulations in key global jurisdictions."

ABHI's recommendations were not substantially different from those of the UK Academy of Medical Sciences, which in October 2020 published the report Lessons Learnt: The Role of Academy and Industry in the UK's Diagnostic Testing Response to COVID-19. The report was the result of a roundtable involving stakeholders from the government, industry, and academia.

The report highlighted multiple future opportunities, including an investment in alliances and networks involving all sectors; the establishment of cross-sectoral task forces to guide strategy in future crises; and greater communication and transparency, both around decision-making as well as with the public. They also called for the "regulatory agility" of the pandemic era to remain in place, allowing the UK to more easily move innovative new tests into routine care.

Some companies have also outlined recommendations on how best to use the lessons of the pandemic to improve UK diagnostics. In July 2021, Roche Diagnostics published The Future of Diagnostics Delivery in the UK. The report shared the change in mindset advocated by those in academia and industry alike, recommending that the NHS focus on outcomes, rather than reimbursement, and take into consideration the patient diagnostic and treatment pathway when weighing whether or not to adopt innovative new tests.

Roche's report also said policymakers should consider how COVID-19 testing infrastructure could be repurposed for early disease screening. And like ABHI, the company recommended that the UK Medicines and Healthcare Products Regulatory Agency should work with the NHS to develop a "world-leading regulatory framework for the diagnostics industry in the UK."

UK policymakers apparently think so, too. In its Life Sciences Vision, published in July 2021, the government said it intends to change its diagnostics services model to be "more proactive," taking advantage of new technologies and changing public behavior. The government also plans to use the pandemic legacy to improve testing for infectious diseases, it said at the time. "The network of laboratories developed to support the testing effort will, once the pandemic is over, be able to support the expansion of research and clinical trials capacity in the UK," the government said. The UK government has also pledged to publish a new diagnostics strategy.

In September 2021, a sprawling 147-page report, called Coronavirus: Lessons Learned to Date, was published by the Health and Social Care and the Science and Technology committees in the British House of Commons. The report noted that the UK, despite being a global leader in diagnostics, was unable to translate its expertise into an operational testing system in the first year of the pandemic. It also said that the government's Test and Trace effort did not fulfil its promise, and recommended that in the future, there should be better coordination between a centralized testing capacity ready to scale at need, plus local-driven testing efforts, such as through partnerships with university labs.

"Operationally, there were major limitations to rolling out testing," acknowledged Richard Kennedy, global VP of biomarker development and medical director for Almac Diagnostics Services, a division of the Craigavon, UK-based Almac Group. Kennedy noted these constraints included a lack of capacity in NHS testing labs and staff shortages, as well as supply chain issues impacting provision of reagents and equipment.

"Later in the pandemic, widespread testing was successfully achieved through partnerships between academia, commercial partners, such as Almac, public bodies and not-for-profit organizations," Kennedy said in an email. For future pandemics, the NHS must be able to leverage these existing partnerships, improved through the pandemic, to "more quickly allow surge testing and the rapid control of the disease."

Kennedy noted that many hospital labs invested in PCR equipment during the pandemic and added staff with molecular testing expertise, creating an installed base of instruments and pool of talent that can be harnessed to run tests for other diseases, such as cancer or chronic conditions.

Making room for new technologies

Judith Breuer is director of the Pathogen Genomics Unit at University College London. A professor of virology, her lab has focused on using whole-pathogen genome sequencing. She is also a co-investigator in the COVID-19 Genomics UK Consortium. According to Breuer, the pandemic changed the way the UK employed higher-complexity technologies like sequencing, and increased familiarity with other molecular testing approaches, like PCR.

"Molecular testing and sequencing became more widespread," said Breuer in an interview. "For example, there has been a shift toward wider use of molecular testing for understanding the causes of respiratory viruses and that could be beneficial."

Before the pandemic, she noted, there was little surveillance of asymptomatic individuals. While not completely new, it was scaled to meet demand, and used to inform public health measures as the pandemic unfolded. "We had to sequence everything we could to see how the virus was evolving and contribute to how public health management was conducted," noted Breuer.

The issue now is that sequencing at that scale is not sustainable for every disease, and next-generation sequencing is not yet a "black box approach" that every diagnostics center in the UK can do. "There are a lot of barriers remaining for use of the most advanced technologies for diagnostic use and the question is, is it fast enough to generate results for patient care," she said.

That being said, Breuer said that industry has become more open to developing innovative infectious disease tests, including those that are sequencing-based, for pathogen detection and patient management. And while the NHS is a "slow moving beast," it too is implementing new technologies into laboratories of excellence that will slowly be adopted within the rest of the NHS. "There is much more interest from research bodies and public health bodies in molecular technologies and how we can improve them," she said.

Making such molecular and sequence-based tests available, however, requires standardization, evidence that they are useful, and cost-benefit analyses. This is slowly being addressed via research grants and collaborations with industry, but it will take time.

"I would say the climate has changed, and there is more sympathy and consideration given to new technologies," remarked Breuer. "But in practice, other than a few centers of excellence, things are not changing yet because the infrastructure and expertise are not yet there."